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Session 4: Addressing Common Challenges—Clinicaltrials.gov Registration and IRB Reviews
Session Chair(s)
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist
Berry Consultants, LLC, United States
AnnCatherine M. Downing, PHARMD
Chief Operating Officer - Lilly Research Laboratories
Eli Lilly and Company, United States
Master Protocols may not fit the standard methods for trial registration or IRB review. This session will have presentations on the unique considerations for registering a Master Protocol on clinicaltrials.gov and submitting for IRB reviews. The registering and review of these innovative designs may require additional interactions to determine registration requirements or educational materials for IRBs unfamiliar with Master Protocols.
Learning Objective : - Explain the standard approach for registering a trial on clinicaltrials.gov and how Master Protocols may differ
- Outline strategies for submissions to IRBs to facilitate an informed and timely review process for these innovative protocols
- Obtain suggestions for interacting with the clinicaltrials.gov and IRB teams and how the interactions and estimated timelines may be different from standard trials
Speaker(s)
Addressing Common Challenges: IRB Review
Heather Dobbins, PHD
National Institutes of Health (NIH), United States
ClinicalTrials.gov Lead Results Analyst, NCBI/NLM
Speaker
Lindsay McNair, MD, MPH, MS
Equipoise Consulting, United States
Principal Consultant